FDA Questions Delay Prostate Cancer Vaccine

The prospects for prostate cancer vaccine Provenge dimmed this morning after the FDA asked for more clinical data to support claims that it’s effective.

Shares of Dendreon got pummeled, falling more than 55% to $7.86 in early trading, after the company’s disclosure of the setback. The FDA’s questions, which also concerned manufacturing of the vaccine, could substantially delay a decision by the agency on the novel treatment for advanced prostate cancer.

A committee of FDA advisors voted 13-4 that existing data had shown the vaccine to be effective, and 17-0 that the vaccine was safe in late March. That sent the stock up 165% in a single day. The agency usually follows the recommendations of its committees but isn’t bound to do so.

Studies submitted by the company showed that Provenge failed to meet the study’s primary goal of slowing the progress of the disease. But an analysis of the data suggested that the drug increased the survival time for its target population — patients whose cancer has spread and who no longer respond to available treatments. The agency could be waiting for data from an ongoing clinical trial. But those results may not be available until 2010, according to the Seattle Times.

To read the Health Blog’s March interview with a prostate cancer specialist who participated in Provenge research, click here.

Health Blog Question of the Day: Did FDA make the right call on Provenge?

Comments (5 of 54)

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4:59 pm May 15, 2007

Steven H wrote :

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8:21 pm May 12, 2007

doctor wrote :

as a medical professional, i have to say no, the right decision was not made in this case. who cares if it doesn't have tpp? what matters to me and to my patients is that they live longer and better. if the drug doesnt work we would figure it out pretty quickly and stop prescribing it. there was no harm in trying. these patients are taking taxotere, which has very low efficacy and severe side effects. shame on the fda for possibly taking precious months of life away from patients

1:16 pm May 11, 2007

Fake-medicine wrote :

Studies of Provenge failed to meet their pre-defined goals -- most importantly, the vaccine didn't appear to slow the spread of prostate cancer in men with advanced disease, and who weren't responding to hormone therapy. But after the studies were completed, an analysis suggested the vaccine may have increased survival by about four months. The research on Provenge generally supported its safety. The biggest difference between Provenge and snake oil is that Provenge treatments cost about $30,000. Maybe Provenge treatment is completely useless against prostate cancer, or maybe it has some small efficacy as the post hoc analysis suggests. Now we won't see many appeals for "compassionate use" with the $30,000 price tag, with insurance not covering the bill.
I think the FDA can't approve a drug where the benefits:cost ratio is tiny, even when the drug is the only safe drug with some efficacy. For one thing, when another more efficacious drug appears that first drug would still have its approval (and its marketing force, etc.). For another thing the FDA must have a responsibility to the public purse. Almost all users of Provenge are over 65 and have Medicare coverage. With approval, most of the $30,000 treatments for small medical benefits were going to be paid from public funds.

5:04 pm May 10, 2007

David Kunze wrote :

NO I am a Matastic -Pca survivor, stage 4 and Gleason 8. I have run out of the traditional Hormone therapies, am now refractory with an very aggressive Pca.
What the FDA is saying is To us is,to hell with us patients. This is another example of some bureaucrats in Washington sitting on their asses making decision that affect our lives!!!!